Using colchicine to treat heart failure with preserved ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of colchicine, an anti-inflammatory drug, on patients suffering from heart failure with preserved left ventricular ejection fraction (HFpEF). The study aims to understand how colchicine can reduce inflammation and lower levels of soluble suppression of tumorigenicity 2 (sST2), which is associated with heart failure. Participants will be monitored for changes in their heart function and inflammatory markers. The trial includes both Phase 1 and Phase 2 assessments to evaluate safety and efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 40 years of age, male and female
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Symptoms and signs of heart failure
* N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥300 pg/ml at baseline (patients in atrial fibrillation at baseline NT-proBNP ≥ 600 pg/ml), left atrial volume index (LAVI) \>34 mL/m2 or a left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females
* body mass index (BMI) \> 30kg/m2 or diabetes mellitus

Exclusion Criteria:

* Hypertrophic cardiomyopathy, constrictive pericarditis, or cardiac amyloidosis
* Acute decompensation of HF in the last 1 month
* Valvular heart disease
* Prior history of LVEF below 50%
* Acute myocardial infarction in the last 3 months, cardiac surgery or cerebrovascular accident within the recent 6 months
* Any active or chronic inflammatory diseases or infections
* Patients with indication for colchicine therapy or history of colchicine intolerance
* Severe hepatic (alanine aminotransferase N3 upper limit of normal or renal dysfunction (estimated glomerular filtration rate \<45 mL/min per 1.73m2)
* Severe nervous system diseases
* History of any malignancy or suffering from cancer
* Lack of informed consent

Where it's running

• A Shchendrygina
  Moscow, Russian Federation Recruiting
• Anastasia Shchendrygina
  Moscow, Russian Federation Recruiting

Study contacts

• Principal investigator: Anastasia Shchendrygina — Sechenov Univerity
• Study coordinator: Anastasia SHCHENDRYGINA
• Email: a.shchendrygina@gmail.com
• Phone: +79262309207

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tamibarotene for HFpEF: see if this drug helps heart failure with preserved ejection fraction

  A 12-week trial tests whether tamibarotene can reduce NT-proBNP levels in adults with HFpEF compared with placebo.

  Recruiting Phase 2 Nagoya University · Nagoya, Aichi-ken and 3 other locations · NCT07855692

• Colchicine in dialysis patients: a feasibility test

  This study tests whether a low daily dose of colchicine is tolerable for adults on haemodialysis over 3 months.

  Recruiting King's College London · London · NCT07762807

• High-intensity interval training guided by cardiopulmonary exercise testing for HFpEF

  This trial tests whether a personalized high-intensity interval training program, guided by CPET results, can help people with heart failure with preserved ejection fraction improve their fitness and symptoms.

  Recruiting Peking University Third Hospital · Beijing and 12 other locations · NCT07693049

• Finerenone in patients having TAVI with heart failure

  This study tests whether finerenone can help people with heart failure and preserved ejection fraction who are undergoing transcatheter aortic valve implantation.

  Recruiting Phase 3 Second Affiliated Hospital, Zhejiang University, School of Medicine · Bengbu, Anhui and 60 other locations · NCT07575672

• Tiny ultrasound bubbles as an alternative to catheters for measuring pressures inside the heart

  This will test whether injecting tiny ultrasound bubbles can estimate heart filling pressures in people who are having a cardiac catheterisation.

  Recruiting King's College London · London · NCT07416279

• Precision colchicine to target atherosclerosis in people with TET2-CHIP after ACS

  This study tests whether including colchicine helps post-ACS patients, guided by TET2-CHIP status, to reduce plaque growth.

  Recruiting Phase 4 Shenyang Northern Hospital · Shenyang, Liaoning · NCT07362966

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.